BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I.B.S®-C COMPRESSION SCREWS

    MDR report key: 23096700 · Received September 19, 2025

    Report

    Report Number
    3010470577-2024-08041
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    June 12, 2024
    Report Date
    September 19, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HWC
    UDI-DI
    03760225710142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD WAS ASSESSED AND AS PER CONTENTS NO NC OCCURRED DURING THE MANUFACTURING PROCESS. NO NC IS IDENTIFIED WHICH MIGHT EXPLAIN THE COMPLAINT. PATIENT ACCIDENT, OUT OF SCOPE OF REASONABLY FORESEEABLE MISUSE.

    Description of Event or Problem · 0

    DEVICE DESCRIPTION: THE I.B.S®-C COMPRESSION OSTEOSYNTHESIS SCREWS ARE INTENDED FOR THE FIXATION OF ARTHRODESIS, OSTEOTOMIES OR FRACTURES OF LONG OR SHORT BONES OF THE UPPER AND LOWER LIMBS. THE SIZE OF THE CHOSEN SCREW SHOULD BE ADAPTED TO THE SPECIFIC INDICATIONS. EVENT DESCRIPTION: ON (B)(6) 2024, CONMED CUSTOMER SERVICE RECEIVED AN EMAIL FROM A PATIENT REPORTING A SERIOUS INCIDENT INVOLVING AN IMPLANTED ORTHOPEDIC SCREW. THE PATIENT UNDERWENT SURGERY IN (B)(6) 2023 DURING WHICH SIX IBS 2.5-C COMPRESSION SCREWS (DIAMETER 2.5 MM, LENGTH 22 MM, T7) WERE IMPLANTED IN THE TOES. ON (B)(6) 2024, THE PATIENT EXPERIENCED AN EVENT WHILE GETTING INTO BED, DURING WHICH THE MIDDLE TOE BECAME CAUGHT IN A RUG. THIS RESULTED IN THE BENDING OF ONE OF THE IMPLANTED SCREWS AND A DAMAGE OF THE TOE. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE BENT SCREW AND REPLACE IT WITH ALTERNATIVE HARDWARE. THE EMAIL INCLUDED A PHOTO OF THE AFFECTED TOE AND THE BENT SCREW. NOTE: THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956664 I.B.S®-C COMPRESSION SCREWS I.B.S® 2.5-C COMPRESSION SCREW - DIAMETER 2.5MM LENGTH 22MM HWC IN2BONES SAS 2304342 03760225710142

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention